- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07826481
Portal and Splenic Venous Pulsatility in Postoperative Critically Ill Patients (PULSE-ICU)
Correlation Between Portal and Splenic Venous Pulsatility Using Doppler Ultrasound as a Marker of Venous Congestion in Postoperative Critically Ill Patients
Venous congestion is common in critically ill postoperative patients and may be associated with adverse outcomes. Doppler ultrasound assessment of venous flow patterns, including portal venous pulsatility, is increasingly used to evaluate systemic venous congestion.
This prospective observational study aims to determine the correlation between portal venous pulsatility and splenic venous pulsatility measured by Doppler ultrasound in adult patients admitted to a postoperative intensive care unit. The study will evaluate whether splenic venous pulsatility may provide additional information for the assessment of venous congestion.
Ultrasound examinations will be performed in addition to standard clinical care, without any therapeutic intervention or modification of patient management.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Systemic venous congestion is increasingly recognized as an important pathophysiological factor in critically ill patients, particularly after major surgery. The Venous Excess Ultrasound (VExUS) grading system combines inferior vena cava assessment with Doppler evaluation of hepatic, portal, and renal venous flow patterns to identify clinically relevant venous congestion.
The portal venous pulsatility index (PI), calculated using pulsed-wave Doppler measurements at the hepatic hilum, has been described as a marker of venous congestion and has shown potential clinical relevance in the assessment of fluid status and decongestion response.
However, splenic venous pulsatility has not been systematically evaluated as a marker of venous congestion in critically ill patients, and its relationship with portal venous pulsatility remains unknown. Since both venous territories drain into the portal system and may reflect retrograde transmission of elevated right atrial pressure, splenic venous pulsatility could represent an additional non-invasive parameter for congestion assessment.
This prospective, observational, single-center study will investigate the correlation between portal and splenic venous pulsatility measured by Doppler ultrasound in postoperative critically ill patients. Secondary objectives include assessment of measurement reproducibility, evaluation of the relationship with VExUS grading, analysis in clinically relevant subgroups, and exploration of the association between splenic venous pulsatility and decongestion during ICU admission.
No experimental treatment will be administered, and all ultrasound assessments will be performed as an additional non-invasive evaluation alongside standard clinical management.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: LUCIA VALENCIA, PHD
- Telefonnummer: 0034928450370
- E-Mail: ORI98ES@YAHOO.ES
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
nclusion Criteria:
Adults aged ≥18 years. Admission to the postoperative intensive care unit within 72 hours after surgery.
Adequate abdominal ultrasound window allowing visualization of the portal vein and splenic vein.
Written informed consent provided by the patient or legally authorized representative according to local regulations.
Exclusion Criteria:
Known chronic liver disease or previous portal hypertension. Previous pathological splenomegaly or prior splenectomy. Recent hepatic or splenic surgery during the same hospitalization. Known portal or splenic vein thrombosis. Absence of an adequate ultrasound window after two attempts by trained operators.
Death or discharge from the intensive care unit before completion of the first protocolized ultrasound assessment.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Correlation between portal venous pulsatility index (portal PI) and splenic venous pulsatility index (splenic PI) measured by Doppler ultrasound.
Zeitfenster: Baseline assessment during the first 72 hours after admission to the postoperative intensive care unit.
|
The primary outcome is the degree of correlation between portal and splenic venous pulsatility indices assessed during the same ultrasound examination in postoperative critically ill patients.
|
Baseline assessment during the first 72 hours after admission to the postoperative intensive care unit.
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- DrNegrinUH0001
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .